Hemostatic Pad Assembly Kit and Method

Abstract

The present invention relates generally to agents and devices for promoting hemostasis and tissue sealing and, more particularly, to hemostatic pads comprising bioabsorbable scaffolds that can deliver lyophilized hemostasis promoting proteins, such as fibrinogen and thrombin, to a wound site or injured organ or tissue.

Description

THE FIELD OF THE INVENTION[0001]The present invention relates generally to agents and devices for promoting hemostasis and tissue sealing and, more particularly, to hemostatic pads comprising bioabsorbable scaffolds that can deliver lyophilized hemostasis promoting proteins, such as fibrinogen and thrombin, to a wound or injured organ or tissue.BACKGROUND[0002]Blood is a liquid tissue that includes red cells, white cells, corpuscles, and platelets dispersed in a liquid phase. The liquid phase is plasma, which includes acids, lipids, dissolved electrolytes, and proteins. One particular protein suspended in the liquid phase is fibrinogen. When bleeding occurs, the fibrinogen reacts with water and thrombin (an enzyme) to form fibrin, which is insoluble in blood and polymerizes to form clots.[0003]In a wide variety of circumstances, animals, including humans, can suffer from bleeding due to wounds or during surgical procedures. In some circumstances, the bleeding is relatively minor, an...

AI Technical Summary

Benefits of technology

[0013]In one embodiment, the scaffold has one or more layers constructed from materials of oxidized polysaccharide, bioabsorbable synthetic polymer or combinations thereof. In an alternative embodiment, the scaffold is a multi-layered structured composite material having a lactide-glycolide polymer layer and a cellulosic layer comprising oxidized regenerated cellulose that are attached to one another. The hemostatic powder is preferably provided on and adheres to the lactide-glycolide polymer layer, while the opposing surface layer comprises the oxidized regenerated cellulose that acts as a reinforcement and handling layer.

[0014]The present invention is also directed to a method of making and using the hemostatic wound treatment pad as described above by wetting the scaffold with the biocompatible liquid; contacting the scaffold with the hemostatic powder and adhering at least a portion of the hemostatic powder to at least the wound facing surface of the scaffold; and applying the wound facing surface of the hemostatic wound treatment pad onto a wound. The time period between initial contact of the scaffold with the hemostatic powder and the subsequent application of the hemostatic wound treatment pad onto the wound is preferably less than two minutes.

[0015]The present invention is also directed to a prep kit for a hemostatic wound treatment pad having at least one powdered hemostatic material; a bioabsorbable scaffold; a biocompatible liquid; and an application tray, wherein these components are combined into a unitary packaging unit. The at least one powdered hemostatic material can be a protein that is selected from the group consisting of fibrinogen, a thrombin, or a mixture thereof. The biocompatible liquid can be selected from the group consisting of water, an aqueous solution, a normal saline, a thrombin solution, a fibrinogen solution, an alcohol, or a glycerol. In one embodiment, the at least one powdered hemostatic material is a mixture of a dry fibrinogen and a dry thrombin and the biocompatible liquid comprises normal saline. In another embodiment, the powdered hemostatic material is dry fibrinogen and the biocompatible liquid is a thrombin containing solution. The kit can further include wetting means for wetting said bioabsorbable scaffold with the biocompatible liquid. Exemplary wetting means can be a liquid transfer pad; a spray bottle; a transfer pen; or a liquid tray having size accommodating immersion of said bioabsorbable scaffold with the wound facing side facing into said liquid tray. The liquid transfer pad includes a bundle of surgical gauze. The powdered hemostatic material can be packaged into the powder tray. The bioabsorbable scaffold can be constructed from one or more distinct layers of a bioabsorbable polysaccharide, a bioabsorbable synthetic polymer, a bioabsorbable protein, or combinations thereof. Alternatively, these materials of construction can be combined into unitary layers. The bioabsorbable scaffold can be a fabric, a woven material, a non-woven material, a mesh, or combinations thereof. In one embodiment, the bioabsorbable scaffold is a multilayer composite structure having a cellulosic layer comprising oxidized regenerated cellulose and a polymer layer comprising Polyglactin 910 that are separate, distinct and fixedly attached to one another.

Problems solved by technology

In other circumstances substantial bleeding can occur.

The nonaqueous adhesive does not allow a hydrolytic reaction to occur between the fibrinogen and thrombin until the bandage is moistened by a body fluid, such as blood and teaches that the bandage can be prepared and stored for prolonged periods while retaining hemostatic activity.

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